Animal Assisted Therapy for Traumatic Brain Injury

Recruiting in Palo Alto (17 mi)

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Children's Hospital Medical Center, Cincinnati

Disqualifiers: Dog allergy, Fear of dogs, Communicable disease, Developmental delay, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial tests whether having dogs in therapy sessions helps children with brain injuries stay engaged in their rehabilitation. The goal is to see if this approach makes therapy more effective and enjoyable for these children.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the treatment Animal Assisted Therapy for Traumatic Brain Injury?

Animal Assisted Therapy (AAT) has been shown to help improve psychological conditions like depression, anxiety, and PTSD by increasing comfort, motivation, and social behaviors. While specific data on traumatic brain injury is limited, these benefits suggest potential positive effects for patients with similar needs. ^{1 2 3 4 5}

Is Animal Assisted Therapy safe for humans?

Animal Assisted Therapy (AAT) is generally considered safe when conducted by certified teams of trained animals and handlers. It is important to ensure proper training and certification to maintain safety and achieve beneficial outcomes. ^{1 2 3 5 6}

How is Animal Assisted Therapy different from other treatments for traumatic brain injury?

Animal Assisted Therapy (AAT) is unique because it involves interactions with animals to promote emotional and physical healing, which is different from other treatments like cognitive behavior therapy (CBT) that focus on changing thought patterns, or acupuncture that targets physical symptoms. AAT provides a comforting and engaging experience that can help improve mood and reduce stress, offering a novel approach compared to more traditional therapies. ^{7 8 9 10 11}

Research Team

Eligibility Criteria

This trial is for children and adolescents aged 4-21 who are in inpatient rehab after a brain injury like TBI or infection. They must be responsive (Rancho score >2), have consent from guardians, and assent to participate. It's not for those with communicable diseases, immune issues, dog allergies/fears, history of animal abuse, or developmental delays before the injury.

Inclusion Criteria

Assent: The child/adolescent must provide a signature indicating assent to participate in the study.

I am admitted for rehab due to a brain injury like TBI, tumor, or infection.

Consent: The family must provide informed consent by parents or legal guardians.

Exclusion Criteria

Behavioral History: Participant or family has a history of animal abuse or cruelty.

You are very scared of dogs.

You have a history of delayed development before your brain injury.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive inpatient rehabilitation with and without animal-assisted therapy to assess engagement and mood

2 weeks

Daily sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Animal Assisted Therapy (Behavioural Intervention)

Trial Overview The study tests if including dogs in physical and occupational therapy sessions improves engagement during rehabilitation for pediatric brain injuries. It uses a crossover design where each patient experiences both standard care and animal-assisted therapy to see which works better.

Participant Groups

Group I: Intervention Experimental Treatment 1 Intervention

animal assisted therapy

Group II: Control Active Control 1 Intervention

Treatment as usual

Who Is Running the Clinical Trial?

Children's Hospital Medical Center, Cincinnati

Lead Sponsor

Trials

844

Recruited

6,566,000+

Steve Davis

Children's Hospital Medical Center, Cincinnati

Chief Executive Officer since 2021

MD

Daniel Ostlie

Children's Hospital Medical Center, Cincinnati

Chief Medical Officer

MD from University of North Dakota

Miami University

Collaborator

Trials

16

Recruited

3,000+

Ohio State University

Collaborator

Trials

891

Recruited

2,659,000+

Dr. John J. Warner

Ohio State University

Chief Executive Officer since 2023

MD, MBA

Dr. Peter Mohler

Ohio State University

Chief Medical Officer since 2023

PhD in Molecular Biology

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Dr. Diana W. Bianchi

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Chief Executive Officer since 2016

MD from Stanford University

Dr. Alison Cernich

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Chief Medical Officer since 2020

PhD in Clinical Psychology from University of Maryland

Findings from Research

Animal-assisted therapy (AAT) has been effective in treating various psychological disorders, such as autism, depression, anxiety, and PTSD, by enhancing comfort, motivation, and self-esteem in clients.

While AAT shows promising outcomes as an adjunct to traditional psychotherapy, there is a need for more evidence-based research to solidify its efficacy and mechanisms of action.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Animal-assisted Therapy to Enrich Psychotherapy. Amerine, JL., Hubbard, GB.[2019]

Animal-Assisted Therapy (AAT) is recognized by therapists as a beneficial intervention for improving various aspects of functioning in participants, but there are concerns regarding its implementation.

Many therapists see potential in Robotic Animal-Assisted Therapy (RAAT) as a viable alternative or preparatory option when live animal interaction is not feasible, although most have not yet used RAAT in practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robotic animal-assisted therapy as a complementary therapy in clinical practice: Exploring animal-assisted intervention professional perspectives. Burr, M., Buntich, J., Gonzalez, M., et al.[2023]

The study developed a wearable system to monitor physiological parameters during canine-assisted therapy (CAT), demonstrating a high accuracy in step counting with a mean error of ≤0.6%.

This research highlights the potential health benefits for both humans and dogs during rehabilitation activities, suggesting a need for further investigation into the mutual effects of AAT on both participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The mHealth in the canine assisted therapy: the design and application of a kit for the wearable monitoring during a walking session. Giansanti, D., Maccioni, G.[2022]

Animal Assisted Therapy (AAT) can significantly enhance rehabilitation outcomes by engaging and motivating patients, but it requires certified and trained therapy teams to ensure safety and effectiveness.

Collaboration between AAT therapists and other clinicians is essential for maximizing treatment opportunities and achieving specific rehabilitation goals, highlighting the need for standardized practices in this emerging field.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Collaboration in Animal-Assisted Activities and Animal-Assisted Therapy. Decina, E., Evangelista, B., Harantschuk, A.[2022]

Cognitive Behavioral Therapy (CBT) has been found effective in reducing external aggressive behaviors in individuals with acquired brain injury (ABI), based on a systematic review of seven studies, including one randomized controlled trial and five pre-post trials.

However, CBT did not significantly impact internal feelings of anger, suggesting that while it helps manage outward aggression, it may not address the underlying emotional issues, indicating a need for further research with control groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive behavioural therapy for aggression among individuals with moderate to severe acquired brain injury: a systematic review and meta-analysis. Iruthayarajah, J., Alibrahim, F., Mehta, S., et al.[2019]

Recent animal studies on blast injuries have revealed that non-cerebral-focused traumatic brain injuries (TBIs) can lead to significant and often overlooked neuropathological outcomes, similar to those observed in a human case report.

The study highlights the importance of understanding the mechanisms of injury, such as the role of the foramen magnum in funneling blast waves, which can cause additional damage beyond the initial impact, emphasizing the need for thorough diagnostic follow-up in TBI cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delayed-Onset Neuropathological Complications From a Foramen Magnum and Occipital Crest-Focused Traumatic Brain Injury of the Vietnam War and Other Conflicts: Part II, Research Analysis. Burkle, FM., Hadley, KS., Ridge, LL., et al.[2022]

Electroacupuncture (EA) treatment for 60 minutes daily over three days significantly reduced neuroinflammation and neuronal damage in a rat model of traumatic brain injury (TBI), as evidenced by decreased infarction volume and apoptosis markers.

The study suggests that EA may enhance functional recovery after TBI by mitigating the inflammatory response, indicated by lower activation of microglia and astrocytes and reduced expression of the inflammatory marker TNF-α.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early electroacupuncture treatment ameliorates neuroinflammation in rats with traumatic brain injury. Tang, WC., Hsu, YC., Wang, CC., et al.[2018]

In a study of 24 adult survivors of traumatic brain injury (TBI), acupuncture improved cognitive function compared to a control group, although it did not significantly change sleep time.

Acupuncture was associated with a better perception of sleep quality in TBI patients, suggesting it may be a beneficial treatment option with fewer cognitive and affective side effects compared to medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acupuncture for treatment of insomnia in patients with traumatic brain injury: a pilot intervention study. Zollman, FS., Larson, EB., Wasek-Throm, LK., et al.[2015]

Cognitive behavior therapy (CBT) tailored for individuals with acquired brain injury (ABI) significantly reduced emotional distress, as evidenced by improvements on the Symptom Checklist-90-Revised and the Depression Anxiety Stress Scales in a study of 20 participants.

The study demonstrated that both group and telephone formats of the adapted CBT were effective, highlighting its flexibility in delivery for individuals with chronic ABI, although no significant changes were noted in community integration or coping strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of cognitive behavior therapy in the treatment of emotional distress after acquired brain injury. Bradbury, CL., Christensen, BK., Lau, MA., et al.[2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

Using Animal-assisted Therapy to Enrich Psychotherapy. [2019]

2. England pubmed.ncbi.nlm.nih.gov

The use of animal-assisted therapy in combination with physical therapy in an inpatient rehabilitation facility: A case report. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Robotic animal-assisted therapy as a complementary therapy in clinical practice: Exploring animal-assisted intervention professional perspectives. [2023]

4. China pubmed.ncbi.nlm.nih.gov

The mHealth in the canine assisted therapy: the design and application of a kit for the wearable monitoring during a walking session. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Collaboration in Animal-Assisted Activities and Animal-Assisted Therapy. [2022]

6. China (Republic : 1949- ) pubmed.ncbi.nlm.nih.gov

[Lassie's magic: animal-assisted therapy in Taiwan]. [2009]

7. England pubmed.ncbi.nlm.nih.gov

Cognitive behavioural therapy for aggression among individuals with moderate to severe acquired brain injury: a systematic review and meta-analysis. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Delayed-Onset Neuropathological Complications From a Foramen Magnum and Occipital Crest-Focused Traumatic Brain Injury of the Vietnam War and Other Conflicts: Part II, Research Analysis. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Early electroacupuncture treatment ameliorates neuroinflammation in rats with traumatic brain injury. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Acupuncture for treatment of insomnia in patients with traumatic brain injury: a pilot intervention study. [2015]

11. United States pubmed.ncbi.nlm.nih.gov

The efficacy of cognitive behavior therapy in the treatment of emotional distress after acquired brain injury. [2018]